Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds

Understanding Barriers to Initiation and Adherence to Adjuvant Endocrine Therapy in Young Breast Cancer Survivors of Diverse Racial, Ethnic, and Socio-economic Backgrounds: The EMPOWER Study

The overall goal of this study is to qualitatively explore how behavioral, cultural, psychosocial, and economic barriers and facilitators affect the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Phone interview

Detailed Description

A qualitative study that will use interviews to gain an in depth understanding of factors affecting the decision to start and adhere to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone receptor positive (HR+) breast cancer

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women of all races

Description

Inclusion Criteria:

• Are Hispanic, Latina, Black, or identify as socio-economically disadvantaged (any racial/ethnic background) as measured by an item of financial distress answering that they are "having difficulty paying the bills no matter what they do" to a question about their current household financial situation.18, 19
• report a history of Stage 1-3 breast cancer
• reports HR+ breast cancer and confirm that they have had a discussion with their doctor about adjuvant ET; OR indicate that they are taking ET, even if they do not know their HR status, answer they are HR-, or do not recall having a discussion about ET)
• not in active treatment (e.g., chemotherapy, radiation), with the exception of Herceptin
• at least 3 months, but no more than 3 years out of completion of active treatment
• no evidence of recurrent/metastatic disease
• at least 18, but< 45 years of age at diagnosis of first invasive breast cancer
• English or Spanish speaking
• are willing to consent to the interview

Exclusion Criteria:

• HR- breast cancer and indicate they are not taking ET
• HR+ breast cancer but do not confirm discussion of ET or indicate they are taking ET
• Stage 0 (DCIS) breast cancer
• Recurrent or metastatic disease
• Less than 3 months or more than 3 years post-active treatment
• Less than 18 years old or ≥45 years old at diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quality Of Life; This study uses qualitative research methods, specifically semi-structured interviews.; This will include moderator guide development,; Phone interviews with breast cancer survivors will be conducted; Qualitative data analysis of the phone interviews will be conducted	Other: Phone interview; Collecting clinical and socio-demographic information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision-making around endocrine therapy in young women with HR+ breast cancer.	Open ended questions	3 months-3 years post active treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers and challenges to endocrine therapy adherence	Open ended questions	3 months-3 years post active treatment
Social support	Open ended questions	3 months-3 years post active treatment
Health behaviors	Open ended questions	3 months-3 years post active treatment
Endocrine therapy adherence intervention preferences	Open ended questions	3 months-3 years post active treatment
Health literacy	Brief Health Literacy Screener (Chew items)	3 months-3 years post active treatment
Menopausal symptoms	BCPT Symptom Checklist	3 months-3 years post active treatment

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 17-581; U54CA156732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No